Title : Bioresorbable Vascular Scaffolds Versus Conventional Drug-Eluting Stents: A Systematic Review and Meta-Analysis of Randomised Controlled Trials
Abstract:
Bioresorbable vascular scaffolds (BVS) are developed as a replacement for conventional drug-eluting stents (DES) used in percutaneous coronary intervention (PCI). They are designed to limit the accrual of late adverse events observed in DES by dissolving once they have restored lasting patency. Despite their initial promise, studies have since raised safety concerns for the period before their resorption (around 2-years).
Objectives: Compare the safety and efficacy of BVS vs contemporary DES in patients receiving PCI for coronary artery disease across a complete range of randomised controlled trial (RCT) follow-up intervals.
Methods: MEDLINE, EMBASE, and Web of Science were searched from inception through 5th January 2022 for RCTs comparing clinical outcomes of BVS vs DES. The primary safety outcome was stent thrombosis (ST), and the primary efficacy outcome was target lesion failure (TLF: composite of cardiac death, target vessel myocardial infarction [TVMI], and ischaemia driven target lesion revascularisation [ID-TLR]). Studies were appraised using Cochrane’s Risk of Bias tool and meta-analysis was performed using RevMan 5.4. This study is registered with PROSPERO: CRD42022301449.
Results: 11,919 patients were randomised to receive either BVS (n = 6,438) or DES (n = 5,481) across 17 trials (follow-up intervals from 3-months to 5-years). BVS demonstrated increased risk of ST across all timepoints (peaking at 2-years with risk ratio [RR]: 3.47; 95% confidence interval [CI]: 1.80 to 6.70; p = 0.0002). Similarly, they showed increased risk of TLF (peaking at 3-years, RR: 1.35; 95% CI: 1.07 to 1.70; p = 0.01) resulting from high rates of TVMI and ID-TLR. Though improvements were observed after device dissolution (5-year follow-up), these were non-significant.
Conclusion: This meta-analysis demonstrates that current BVS are inferior to contemporary DES throughout the first 5-years at minimum.
What will the audience learn from your presentation?
My presentation will be centered around the following points:
- The limitations of currently used drug-eluting coronary stents (DES).
- How bioresorbable vascular scaffolds (BVS) were designed to improve on them.
- That recent research (including our systematic review and meta-analysis) demonstrates that BVS are in fact inferior to conventional DES in both safety and efficacy outcomes.
- The reasons why this is suspected to be the case, and how BVS may be improved in future.
This information provides further insight to clinicians when deciding what stent they use/recommend, and may inform how they discuss these choices with their patients. It is hoped that the presentation will drive further research comparing long term follow-up of BVS versus DES, to establish if the risk balance changes long after device dissolution. Furthermore, the reasons why BVS deliver inferior safety and efficacy profiles compared to DES should drive continued progress in future stent design.
